22 days ago
Our Client, a Global Pharmaceuticals Company based in Essex are looking for a Regulatory Affairs Executive to join their fast growing yet well established team.
The role will be based in Essex with remote working flexibility.
Main responsibilities & duties as Regulatory Affairs Executive will include;
- Provides operational regulatory support to project management on new divestment projects, technical transfer, CMOs, quality assurance and commercial departments.
- Supports the preparation of core dossiers and submissions for global roll out.
- Authors and collates supporting documents for submission, including M1 and M3 dossier sections as necessary, justification documents and Product Information.
- Supports labelling processes, providing artwork approval prior to submissions and printing.
- Monitor's labelling compliance across multiple markets, coordinates the review of the Company Core Data Sheet (CCDS) and subsequent safety updates globally.
- In collaboration with global partners, consultancies, and distributors, supports he compilation of global regulatory intelligence to form a global regulatory strategy.
- In collaboration with senior management and project strategy teams, supports global cross functional regulatory strategies.
- Ensure diligent reporting and progress updates on regulatory workload at weekly/bi-weekly internal regulatory meeting.
- Interprets applicable regulations and guidelines for project team use. Keeps project team abreast of regulatory decisions, evolving regulatory requirements, risks, and mitigation plans.
- Communicated with local health authority (HA(s), local consultancies/ distributors, and internal stakeholders, as needed, to ensure timely and accurate submissions.
- May support or facilitate communication between the HA(s) and the project team. Attends and generally leads agency meetings, if required.
- Coordinates and solicits components of the submission from various functional areas, distributors and CMOs.
- Proactively identifies project issues to the project team and supports mitigation plans.
- Attends cross functional meetings, vendor meetings and kick-off meetings as required.
- Maintains a high level of professional expertise through familiarity with scientific literature and participation in training courses.